BACKGROUND: Because of limitations in observational studies, a randomized controlled trial (RCT) would help clarify whether hormonal contraception increases the risks of acquiring a sexually transmitted infection (STI). However, the feasibility of such a trial is uncertain. STUDY DESIGN: We conducted a study to assess the feasibility of conducting a RCT that would compare the acquisition risk for Chlamydia trachomatis and Neisseria gonorrhoeae in women randomized to an intrauterine device (IUD) or depot medroxyprogesterone acetate (DMPA). In our cross-sectional survey conducted at three clinics, we gave information on a potential RCT to clients, asked them questions to assess comprehensibility and finally asked respondents whether they would consider enrolling in such a trial. In addition, the 190 participants provided urine or endocervical swab specimens so we could estimate the prevalence of STIs. RESULTS: Overall, 70% of participants stated that they would take part in a future trial and accept randomization to either the IUD or DMPA. Participant understanding of the trial requirements was high. Twenty-nine percent of the participants were infected with either N. gonorrhoeae or C. trachomatis. CONCLUSION: With a high prevalence of STI in this population and the apparent willingness of appropriate candidates to participate, an RCT to measure risks of incident STI infection from hormonal contraception appears feasible.
RCT Entities:
BACKGROUND: Because of limitations in observational studies, a randomized controlled trial (RCT) would help clarify whether hormonal contraception increases the risks of acquiring a sexually transmitted infection (STI). However, the feasibility of such a trial is uncertain. STUDY DESIGN: We conducted a study to assess the feasibility of conducting a RCT that would compare the acquisition risk for Chlamydia trachomatis and Neisseria gonorrhoeae in women randomized to an intrauterine device (IUD) or depot medroxyprogesterone acetate (DMPA). In our cross-sectional survey conducted at three clinics, we gave information on a potential RCT to clients, asked them questions to assess comprehensibility and finally asked respondents whether they would consider enrolling in such a trial. In addition, the 190 participants provided urine or endocervical swab specimens so we could estimate the prevalence of STIs. RESULTS: Overall, 70% of participants stated that they would take part in a future trial and accept randomization to either the IUD or DMPA. Participant understanding of the trial requirements was high. Twenty-nine percent of the participants were infected with either N. gonorrhoeae or C. trachomatis. CONCLUSION: With a high prevalence of STI in this population and the apparent willingness of appropriate candidates to participate, an RCT to measure risks of incident STI infection from hormonal contraception appears feasible.
Authors: Deborah Bartz; Rie Maurer; Jessica Kremen; Jennifer M Fortin; Elizabeth Janiak; Alisa B Goldberg Journal: Contracept Reprod Med Date: 2017-01-07